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Completed

NCT Number: NCT04174300

Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)

Fibromyalgia (FM)and Chronic Fatigue Syndrome (CFS) are complex diseases often presenting overlapping symptomatology. Manual therapy (MT) protocols report benefits for pain treatment of FM, but the underlying mechanisms for patient improvement remain unknown.

The main goal of this study is to assess the molecular changes associating to mechanical and additional MT triggers, possibly involved in patient symptom improvement.

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Key information

Conditions

Fibromyalgia (FM) Chronic Disease Chronic Fatigue Syndrome (CFS) Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinicas Universitarias UCV

Valencia, 46001, Spain

About this study

Patients with Fibromyalgia as primary diagnosis assessed by the 1990 & 2010 ACR (American College of Rheumatology) criteria, presenting or not comorbid CFS, according to the Canadian and International CFS criteria, age 40-75 and BMI<35 (N=40), will be subjected to physiotherapy treatment consisting on 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N by a single operator (Collegiate Physiotherapist). Blood samples (10-20mls/participant) will be obtained before and after first treatment, and after fourth and last treatment to determine molecular blood changes associated to the physiotherapy protocol applied. PBMC (Peripheral Blood Molecular Cells) transcriptome before and after treatments (RNAseq) will be studied towards identifying treatment-associated differential expression, mechanomiR profiles included. Patient health status with treatment will be monitored by FIQ, MFI and SF-36 questionnaires, in addition to an anonymized satisfaction questionnaire to register potential undesired secondary effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of FM with or without comorbid CFS
  • Not receiving hormone therapy
  • Not suffering from other diseases
  • Without previous history of cancer
  • Not actively participating in any pharmacological trial
  • Not taking medication for at least 12 hours before blood draw
  • Having signed informed consent

Exclusion criteria

  • Any uncompliance with what is described as inclusion criteria

Treatment and study plan

Manual Therapy

Procedure

8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N

Other names: Physiotherapy treatment

Primary outcomes

  1. Fatigue score

    Time frame: 8 weeks

    MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue

  2. Pain index

    Time frame: 8 weeks

    FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, <39 mild, 39-58 moderate, ≥59 severe

  3. Differential gene expression

    Time frame: 8 weeks

    RNAseq

Secondary outcomes

  1. Quality of life score

    Time frame: 8 weeks

    SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health

  2. ANS (autonomic nervous system) dysfunction

    Time frame: 8 weeks

    Plantar pressure maps

Other outcomes

  1. Subjective response to treatment

    Time frame: 8 weeks

    Custom-made questionnaire, -1 to +1 scale (ítems 1-5), scale 1-10 (item 6), 6 items total, higher scores indicate improvement of symptoms

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 22, 2019
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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